Safety and Immunogenicity of a Sub-unit Protein CD40.RBDv Bivalent COVID-19 Vaccine, Adjuvanted or Not, as a Booster in Volunteers.

NCT06255626 | Recruiting Phase 1 DMC

• 2 other identifiers: ANRS0407s - LKV.Cov402023-504594-20-00
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial, on healthy volunteers, is to learn more about safety and reactogenicity of the CD40.RBDv vaccine. The main questions that will be studied are :

• Is the CD40.RBDv (adjuvanted or not) safe ?
• Does the CD40.RBDv (adjuvanted or not) imply an immunologic response ? Participants will receive, depending on their randomization arm, 1 or 2 injections of the CD40.RBDv vaccine or a single injection of approved mRNA vaccine

Conditions

COVID-19

Keywords

Vaccine; COVID-19

Outcome Measures

Primary Outcomes (2)

• Proportion of participants without any grade 3 or 4 biological or clinical solicited local/systemic or unsolicited AEs between D1 and Month 3 after each IMP/vaccine administration and considered to be related or possibly related to IMP administration

  These proportions of participants will be described with its 95% two-sided confidence interval.

  Month 3

• Neutralization antibodies titers (anti-RBD) against the original strain D614G and the relevant strain circulating at time of the study Month 1

  The primary immunogenecity endpoint is the neutralization antibodies titers (anti -RBD) against the original strain D614G and the relevant strain circulating at time of the study Month 1 after each dose The geometric mean titers (GMTs) with 95% confidence intervals (CIs) will be calculated at baseline and at Month 1 after each dose.

  Month 1

Secondary Outcomes (11)

• Number of volunteers with solicited local and systemic Adverse Reactions (ARs)

  Day 8

• Number of volunteers with Adverse Events (AEs) other than solicited adverse events

  Day 1 to Months 3 after each dose

• Number of volunteers with Serious Adverse Events (SAEs), grade 3 and grade 4

  Day 1 to Months 3 after each dose

• Number of volunteers with events leading to discontinuation of the vaccine regimen

  Through study completion, an average of 15 months

• Seroconversion rate defined by an increase of 4 folds between day1 (baseline before vaccination) and Month 1 in anti-RBD IgG binding titers

  Month 1

Study Arms (4)

1-CD40.RBDv non adjuvanted or mRNA vaccine (5:1 ratio)

EXPERIMENTAL

Low dose (LD) CD40.RBDv vaccine non adjuvanted or mRNA vaccine (5:1 ratio). If randomized to receive LD CD40.RBDv vaccine non adjuvanted in part 1, the subject will be randomised a second time to receive LD CD40.RBDv vaccine non adjuvanted (1:1) in part 2. Following a substancial amendment the randomization to mRNA vaccine has been removed from study design

Drug: CD40.RBDv vaccin (SARS-Cov2 Vaccin)

2-CD40.RBDv vaccine adjuvanted or mRNA vaccine (5:1 ratio)

EXPERIMENTAL

LD CD40.RBDv vaccine adjuvanted or mRNA vaccine (5:1 ratio) If randomized to receive LD CD40.RBDv vaccine adjuvanted in part 1, the subject will be randomised a second time to receive LD CD40.RBDv vaccine adjuvanted (1:1) in part 2. Following a substancial amendment the randomization to mRNA vaccine has been removed from study design

Drug: CD40.RBDv vaccin (SARS-Cov2 Vaccin)

3-High dose (HD) CD40.RBDv vaccine non adjuvanted or mRNA vaccine (5:1 ratio)

EXPERIMENTAL

High dose (HD) CD40.RBDv vaccine non adjuvanted or mRNA vaccine (5:1 ratio) If randomized to receive HD CD40.RBDv vaccine non adjuvanted in part 1, the subject will be randomised a second time to receive HD CD40.RBDv vaccine non adjuvanted (1:1) in part 2. Following a substancial amendment the randomization to mRNA vaccine has been removed from study design

Drug: CD40.RBDv vaccin (SARS-Cov2 Vaccin)

4-High dose (HD) CD40.RBDv vaccine adjuvanted or mRNA vaccine

EXPERIMENTAL

HD CD40.RBDv vaccine adjuvanted or mRNA vaccine (5:1 ratio) If randomized to receive HD CD40.RBDv vaccine adjuvanted in part 1, the subject will be randomised a second time to receive HD CD40.RBDv vaccine adjuvanted (1:1) in part 2. Following a substancial amendment the randomization to mRNA vaccine has been removed from study design

Drug: CD40.RBDv vaccin (SARS-Cov2 Vaccin)

Interventions

CD40.RBDv vaccin (SARS-Cov2 Vaccin) DRUG

1 or 2 injection(s) of CD40.RBDv vaccine (or mRNA vaccine 1 injection (5:1))

Also known as: COVID-19 mRNA vaccine

1-CD40.RBDv non adjuvanted or mRNA vaccine (5:1 ratio); 2-CD40.RBDv vaccine adjuvanted or mRNA vaccine (5:1 ratio); 3-High dose (HD) CD40.RBDv vaccine non adjuvanted or mRNA vaccine (5:1 ratio); 4-High dose (HD) CD40.RBDv vaccine adjuvanted or mRNA vaccine

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers Age ≥18 and \<85
• Able to understand and comply with planned study procedures and sign an informed consent before performance of any study-related screening procedures
• Subjects has adequate organ functions, evidenced by normal ALT, AST, and alkaline phosphatase
• Normal haematology lab values
• Negative virology assessment
• Normal Urine testing
• Volunteers must meet the eligibility criteria in the approved package labelling of the active comparator
• For women of childbearing potential: use of an effective contraceptive method and negative pregnancy test. For male participants, use of an effective method of contraception with their partner

You may not qualify if:

• Acute febrile infection within the previous 72 hours and/or presenting symptoms suggestive of COVID-19 or SARS CoV 2 infection within the previous 28 days
• Immunosuppressive medications received within last three months before first IMP administration or within 6 months for chemotherapies
• Immunoglobulins within 90 days before first IMP administration
• Blood products within 120 days before first IMP administration
• Any medical condition, such as cancer, that might impair the immune response
• Use of any experimental therapy
• Intent to participate in another study of an investigational research agent within 4 weeks prior to the enrolment visit or until the end of the study
• Currently pregnant or breastfeeding
• History of severe adverse events following vaccine administration
• Any bleeding disorder considered as a contraindication to an intramuscular injection
• A condition that requires active medical intervention or monitoring to avert grave danger to Asthma other than mild, well-controlled asthma.
• Hypertension
• BMI ≥ 40 kg/m2; ≤ 18 kg/m2; or BMI ≥ 35 kg/m2 with 2 or more of the following: age \> 45, current smoker, known hyperlipidemia, blood pressure is defined as consistently ≥ 140 mm Hg systolic and ≥ 90 mm Hg diastolic
• Malignancy
• Asplenia

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Vaccine Research Institute (VRI), France: collaborator
• EnnoDc (previously known as LinKinVax): collaborator

Study Sites (2)

Hopital Henri Mondor

Créteil, 94000, France

RECRUITING

Hôpital Cochin

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

CVnCoV COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Yves Levy, MD

CONTACT

+33149814442; yves.levy@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open label study. Immunological assessors, only, will remain blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 13, 2024
• Study Start: May 27, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)